• The Korean Journal of Applied Statistics
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• v.33 no.2
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• pp.137-145
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• 2020

Phase I clinical trials (Dose Finding Studies) are the first step in administering new drugs developed through animal experiments or in vitro experiments to humans. An important area of interest in designing Phase I clinical trials is determining the dose that provides the greatest efficacy and acceptable safe dose to the patient. In this paper, we propose a method to determine the maximum tolerated dose considering efficacy and safety using Biased coin design and stopping rule. The proposed method is compared with existing methods through simulation.

• Communications for Statistical Applications and Methods
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• v.19 no.6
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• pp.877-884
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• 2012

Phase I trials determine the maximum tolerated dose(MTD) and the recommended dose(RD) for subsequent Phase II trials. In this paper, a MTD estimation method applied to a biased coin design is proposed for Phase I Clinical Trials. The suggested MTD estimation method is compared to the SM3 method and the NM method (Lee and Kim, 2012) using a Monte Carlo simulation study.

• Journal of the Korean Statistical Society
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• v.14 no.1
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• pp.48-55
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• 1985

In clinical trials subjects are avalible sequentially and must be assigned to treatments immediately. Completely randomized procedure for the allocation of treatments to each subject may result in severe imbalance among the number of subjects in treatment groups, especially for small experiments or interim analyses of large experiments. In this study, restricted randomization methods such as biased coin designs (Efron, 1971), permuted block design, and truncated binomial design are compared to teh completely randomized design in the presence of selection and/or accidential bias by Monte Carlo simulations.